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Medical Dressings--Surgical Films
EUDAMEDClass I (EU MDR)
Ref 1204Model D/Surgical FilmsRef MDN 1204Model D6585
Identity
- Trade Name
- Medical Dressings--Surgical Films EUDAMED
- Device Name
- Medical Dressings EUDAMED
- Model / Reference
- D/Surgical Films EUDAMED1204 EUDAMEDD6585 EUDAMEDMDN 1204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975670551965 EUDAMED
- Basic UDI-DI
- 697567055ddressingsBF EUDAMEDB-16975670551965 EUDAMED
- Direct Marketing DI
- 16975670551965 EUDAMED
- EMDN Code
- M04010202 POLYURETHANE FIXING DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medical Dressings--Surgical Films by Shandong Shingna Medical Products Co., Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697567055ddressingsBF | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697567055ddressingsBF | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Shingna Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000001937
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 551c0070-0e57-4c67-b268-5dc045772bc1 61 fields · synced Oct 6, 2026
- EUDAMED f440c1ce-f07f-4522-b101-5d0796cb7afa 61 fields · synced May 19, 2026